Newsletters

The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.

• Newsletter archive

Human medicines highlights, published monthly, contains key information on human medicines and changes to regulatory processes in the past month. These highlights do not cover all the Agency's activities in the area of human medicines.

EMA provides an RSS feed of the human medicines highlights. To subscribe, use the below link and follow our user guide on how to subscribe to RSS feeds:

• Human Medicines Highlights newsletter

EMA does not collect any personal data from you when you subscribe to this RSS feed.

The newsletter for micro-, small- and medium-sized enterprises (SMEs), published four times a year, provides key updates to SMEs on the European regulatory environment.

For older editions, see the Newsletter archive.

• Report on the 10th anniversary of the SME initiative

What's new in pharmacovigilance, published four times a year, updates qualified persons for pharmacovigilance on guidance, regulations and events.

EMA's ‘CTIS newsflash’ contains key updates on the latest developments, including system improvements, and links to useful reference materials.

Issues from July 2023 (Issue 15) onwards are available at the link below: 

• Clinical Trials Highlights: Issue 15 onwards

Previous issues are available on EMA's website in PDF format: 

• Clinical Trials Highlights: Issues 1 - 14 

Issues from September 2023 (Issue 13) onwards are available at the link below: 

• Veterinary Medicines Highlights: Issue 13 onwards

Previous issues are available on EMA's website in PDF format: 

• Veterinary Medicines Highlights: Issues 1 - 12 

Issues from June 2023 (Issue 6) onwards are available at the link below: 

•    Big Data Highlights: Issue 6 onwards

Previous issues from 2022 are available on EMA's website in PDF format: 

•    Big Data Highlights: Issues 1 - 5

The electronic Application Form (eAF) - Product Management Service (PMS) newsletter provides pharmaceutical companies and national competent authorities in the EU updates on the progress of the eAF and PMS products. It also includes an overview of upcoming events and information on available resources.

The objective of the eAF product is to replace PDF eAFs used for regulatory submissions with online forms available on the Product Lifecycle Management (PLM) Portal, in order to make completing and handling applications more efficient.

For more information, see:

• PLM Portal
• eSubmissions: PLM Portal eAF (DADI)

The Product Management Service (PMS) makes available comprehensive and consolidated data on centrally authorised products (CAPs) and non-centrally authorised products (non-CAPs) from different sources across the European Medicines Regulatory Network.

The data can be re-used in electronic applications and throughout regulatory processes.

For more information, see:

• Substance and product data management services